Consumers and health professionals are advised that since the statement below was published, the TGA has confirmed more cases of anaplastic large cell lymphoma (ALCL) in Australian patients, with a total of 56 cases reported to date.

The Medical Journal of Australia last month published an article discussing anaplastic large cell lymphoma (ALCL) in the context of the Australian Breast Device Registry and advocating strategies to strengthen the registry.

Accordingly in the 'How can the risk be reduced?' section of 'Information for health professionals' contained within our original statement below, our advice regarding pocket irrigation has been updated slightly.

As part of the TGA's ongoing monitoring of the association between breast implants and anaplastic large cell lymphoma (ALCL), consumers and health professionals are advised that an expert advisory panel was convened to discuss the issue on 16 November 2016 and has been providing ongoing advice.

Breast implant-associated ALCL is a rare type of lymphoma that develops near breast implants. The TGA published safety communications regarding this issue on 27 January 2011 and 27 September 2016.

Since our last safety communication, the TGA has been provided with additional data and is advising that 46 cases of breast implant-associated ALCL have now been confirmed in Australia, including three that resulted in death. These cases have all occurred since 2007. Most cases of breast implant-associated ALCL are cured by removal of the implant and the capsule surrounding the implant, however a small number are more aggressive.

The TGA is also aware of a small number of unconfirmed cases. These are being investigated. Consumers and health professionals are asked to report any suspected cases to the TGA.

Future TGA actions

The TGA will work with research groups to obtain better estimates of the risk of breast implant-associated ALCL.[1]

The TGA will work with manufacturers, Australian experts on breast implant-associated ALCL, and Australian experts on breast augmentation and reconstructive surgery to evaluate the benefit-risk balance of the various types of breast implants.

The TGA will continue to liaise with its major overseas regulatory partners and collaborate in international working groups.

Information for consumers

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The expert advisory panel has provided the following 'Q&A':

What is breast implant-associated ALCL?

Breast implant-associated ALCL is a rare type of cancer.

It usually involves a swelling of the breast, typically 3 to 14 years after the operation to insert the breast implant. This swelling is due to an accumulation of fluid. Breast implant-associated ALCL has been known to occur as soon as 1 year after the operation and as late as 37 years after the operation.

Less commonly, breast implant-associated ALCL can take the form of a lump in the breast or a lump in the armpit.

If you notice any of these problems (swelling or a lump), or have any other concerns with your implants, you should seek medical attention.

Most cases of breast implant-associated ALCL are cured by removal of the implant and the capsule surrounding the implant.

What is the risk?

Based on the currently available data, it is not possible to provide an accurate estimate of risk. Current expert opinion puts the risk of ALCL at between 1-in-1,000 and 1-in-10,000. Based on currently available data, most (95%) of cases of breast implant-associated ALCL occur between 3 and 14 years after the implant (median: 8 years; range: 1-37 years).

It can be difficult to express this risk in a concrete way, such that you can make a fully informed decision about whether or not to have a breast implant. Some different ways of expressing the risk are given below:

One woman will be diagnosed with breast implant-associated ALCL for every 1000 to 10,000 women with breast implants.

Suppose we took 1-in-5000 women, the middle of the experts' range, as the best estimate of risk of ALCL in women who have breast implants. This would mean that, of 5000 women with implants, one woman will develop ALCL over a period of about 3-14 years following an implant; the other 4999 women will not develop ALCL.

Should implants be removed, just in case?

Because breast implant-associated ALCL is rare, experts do not recommend removal of breast implants for women who have no problems with the implant.

If you are concerned you should discuss your options with your doctor.

Generally, breast implants are not lifetime devices regardless of breast implant-associated ALCL. Typically they are removed after 10-15 years. The longer you have the implant, the more likely it will need to be removed. Common reasons for removal are contracture (hard or painful implants) or movement of the implant.

How is breast implant-associated ALCL diagnosed?

If you develop swelling of an implanted breast your doctor will send you for an ultrasound scan to see if this is due to a fluid collection. If fluid is present it will be removed and sent to the laboratory for analysis. Most fluid collections are not ALCL, but the laboratory test will be able to tell for sure.

Mammograms are not helpful for diagnosing ALCL.

Other investigations such as MRI and CT-scans would typically be done if the laboratory analysis of the fluid confirms a diagnosis of ALCL.

Should women with implants be screened for ALCL?

Based on external expert clinical advice received by the TGA, regular screening is not recommended at this time.

If you notice enlargement or swelling of one or both breasts, or a lump, you should seek medical advice as soon as possible.

Are some women more at risk of breast implant-associated ALCL than others?

Breast implant-associated ALCL can develop regardless of whether the implant is inserted for cosmetic reasons or for reconstruction of the breast following breast cancer.

It can occur with both saline and silicone gel filled implants.

To date:

No Australian cases have been reported in women who have only had smooth implants.

All Australian cases have occurred in women who have had textured or polyurethane implants.

Based on the currently available data:

It is uncertain whether textured (either micro or macro) and polyurethane implants carry different risks.

It is uncertain whether different brands of textured and polyurethane implants carry different risks.

It is not possible to predict which women with textured or polyurethane implants will develop breast implant-associated ALCL.

What is the prognosis and treatmentof breast implant-associated ALCL?

Most cases are cured by removal of the implant and capsule surrounding the implant. Usually your doctor will remove both implants, even if breast implant-associated ALCL has only occurred in one breast. This is because there is a small but real risk that breast implant-associated ALCL can develop in the opposite breast.

Sometimes there is a solid lump (not just fluid). In these cases, chemotherapy or radiotherapy may be required.

Over the last 10 years, three Australian women have died from breast implant-associated ALCL.

The management of breast implant-associated-ALCL is multidisciplinary with all patients requiring a referral to a surgeon experienced with breast implants and the involvement of a haematologist who specialises in lymphoma, for initial and ongoing investigations and management.

Information for health professionals

Based on advice from Australian experts in cosmetic and reconstructive breast surgery, cancer epidemiology, and lymphoma (i.e., the expert advisory panel), the TGA is providing the following information to health professionals. Because breast implant-associated ALCL (BIA-ALCL) is rare, various aspects of this disease are not fully characterised. A more complete picture is expected over coming years. Health professionals should keep themselves apprised of the latest evidence.

The expert advisory panel has provided the following 'Q&A':

What is breast implant-associated ALCL?

This is a rare form of non-Hodgkin lymphoma. In 2016, the WHO classified breast implant-associated ALCL as a distinct clinical entity, separate from other categories of ALCL.[2]

Unique characteristics include:

being purely T-cell

having no anaplastic lymphoma kinase gene translocation (ALK-)

being CD30 receptor protein positive on immunohistochemistry

being in close anatomical association with a breast implant.

What should women be told about breast implant-associated ALCL?

The possibility of breast implant-associated ALCL should be included in informed consent. The disease is rare. A one-number estimate of the risk is not possible with the currently available data. Current expert opinion is that the risk is between 1-in-1000 and 1-in-10,000 women with implants. Most cases occur between 3 and 14 years after insertion of the implant (median: 8 years; range: 1-37 years).

Based on the currently available data, breast implant-associated ALCL does not seem to occur when only smooth implants are used. All Australian cases to date have occurred in women with textured or polyurethane implants.

Women with implants should be made aware of the common presenting symptoms: delayed effusion/seroma or, less commonly, a mass or lymphadenopathy.

Based on the current epidemiological evidence, the expert panel advised the TGA that breast implants were likely to be a necessary, but not sufficient, cause of breast implant-associated ALCL. The expert panel's reasoning included:

the ALCL cells occur in close proximity to the implant

breast implant-associated ALCL is a distinct clinical entity, separate from other categories of ALCL2

ALCL, with the distinct features of breast implant-associated-ALCL (e.g., ALK-negative, CD30-positive, typical clinical course), has not been reported in the absence of an implant.

The expert panel emphasised that, as with other cancers, the complete set of causal factors is unknown.[3] To date, no patient-specific susceptibility factors, which might help predict risk, have been identified.

How can the risk be reduced?

The currently available data suggest that the risk might be reduced by using smooth implants.

In addition, a hypothesis currently in favour, but not proven, is that T-cell stimulation due to a chronic bacterial biofilm infection increases the risk of ALCL developing. Therefore, standard-of-care precautions, such as antibiotic prophylaxis, pocket irrigation, sterility, and skin preparation should be maintained when placing an implant. It is also hypothesised that such precautions would have the additional benefit of reducing the risk of contracture.

A group of Australian breast implant researchers have made the following recommendations:[4]

Use intravenous antibiotic prophylaxis at the time of anaesthetic induction.

Avoid periareolar incisions; these have been shown in both laboratory and clinical studies to lead to a higher rate of contracture as the pocket dissection is contaminated directly by bacteria within the breast tissue.

Use an introduction sleeve. We have recommended the use of a cut-off surgical glove to minimise skin contact.

Use new instruments and drapes, and change surgical gloves prior to handling the implant.

Minimise the time of implant opening.

Minimise repositioning and replacement of the implant.

Use a layered closure.

Avoid using a drainage tube, which can be a potential site of entry for bacteria.

Use antibiotic prophylaxis to cover subsequent procedures that breach skin or mucosa.

For women who already have implants, the current consensus of expert opinion is that screening or prophylactic removal in asymptomatic patients is not recommended.

How should a suspected case of breast implant-associated ALCL be investigated?

The main method of investigation is ultrasound evaluation to confirm the presence and extent of an effusion, determine if there is presence of a mass, and evaluate regional lymph node basins for lymphadenopathy. Fine needle aspiration (+/- or core biopsy) of an effusion (mass) is performed and the aspirate (tissue) sent, for cytology (histology) and flow cytometry +/- molecular studies, for confirmation of the diagnosis of breast implant-associated ALCL. PET/CT and MRI are reserved for confirmed cases. There does not appear to be a role for mammography.[5]

How should a confirmed case be managed?

The management of this condition is multidisciplinary and all patients require a referral to a surgeon experienced with breast implants and the involvement of a haematologist who specialises in lymphoma, for initial and ongoing investigations and management.

Curative treatment for most women is removal of the implant and oncological capsulectomy, which includes complete resection of any mass associated with the capsule. Contralateral breast implants should be removed with complete capsulectomy because several bilateral cases have been detected incidentally. Both the capsule and fluid should be sent for pathology.[5]

Most diagnosed cases are adequately treated with complete capsulectomy and implant removal. However, aggressive variants have been reported. To date, three deaths have occurred in Australia.

The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device